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A study comparing two injection treatments for oral submucous fibrosis to improve mouth opening

Evaluation of Intralesional i-PRF Versus Triamcinolone Acetonide with Hyaluronidase in the Management of Oral Submucous Fibrosis: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110532
Enrollment
144
Registered
2026-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Injectable platelet-rich fibrin: Injectable platelet-rich fibrin (i-PRF): Approximately 2 mL administered via intralesional injection into fibrosed oral mucosal tissues once weekly for

Sponsors

Department of Dentistry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 years or above Clinically diagnosed OSMF Grade 1-3 according to Khanna and Andrade classification Willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: Grade 4 OSMF Oral epithelial dysplasia or malignancy Systemic conditions affecting healing Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
Maximum Mouth Opening(MMO)Timepoint: Baseline, Weeks 1 6, 2 & 3 months—

Secondary

MeasureTime frame
Burning sensationTimepoint: Baseline, Weeks 1 6, 2 & 3 months;Cheek flexibilityTimepoint: Baseline, Weeks 1 6, 2 & 3 months;Adverse eventsTimepoint: Throughout study—

Countries

India

Contacts

Public ContactDr Sibgutulah Rashid

All India Institute of Medical Sciences, Patna

naqoosh.haidry@gmail.com7096843640

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026